Thank you for your interest in patient enrollment for the phase I clinical study of RM-1929 and photoimmunotherapy in patients with recurrent head and neck cancer. This clinical study is being conducted by the company Aspyrian Therapeutics Inc. in various hospitals located in the USA.

This response provides more details on photoimmunotherapy, clinical study eligibility, clinical trial location sites and contact information for specific clinical trial sites. You can receive more information regarding the study duration and potential risks from the clinical trial site Principal Investigators indicated below.

What is Photoimmunotherapy?

Photoimmunotherapy is an experimental anticancer technology invented at the National Cancer Institute, USA. The investigational drug RM-1929 is based on the Photoimmunotherapy technology, and is designed to bind to head and neck squamous cancer cells and kill the cancer after activation of RM-1929 with red light, which is applied locally at the site of the tumor using a laser.

Who is eligible to participate in this clinical trial?

The study is designed for patients with recurrent squamous cell carcinoma of the head and neck, who in the opinion of their treating physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy.

Patients who may be able to participate in the clinical trial will need to comply with the eligibility criteria. More information about RM-1929 and the trial can be found at Clinicaltrials.gov, under the registration identifier NCT02422979.

How do I find out more information about this clinical trial and if I am able to participate?

If you or someone you know has recurrent or relapsed head and neck cancer, you may contact any of the Principal Investigators at one of the clinical trial sites listed below to receive more information on the clinical trial as well as to determine whether you would be able to participate in the clinical trial. Currently, there are four active clinical trial sites located at various hospitals in the USA, including Colorado, Illinois, Minnesota, and Oklahoma.

United States, Chicago, Illinois

Rush University Cancer Center

Chicago, Illinois, United States, 60612

Contact: Pam Sroka, BS, MT (ASCP), BSN, RN, CCRC

Telephone: 1-312-942-5526

Email: pamela_sroka@rush.edu

Principal Investigator: Mary Jo Fidler, MD

Principal Investigator: Kerstin Stenson, MD

United States, Oklahoma City, Oklahoma

University of Oklahoma Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Contact: Dena Suthers

Telephone: 405-271-8001

Email: dena-suthers@ouhsc.edu

Principal Investigator: Nilesh Vasan, MD

United States, Denver, Colorado

Centura Health Research Center

Denver, Colorado, United States, 80210

Contact: Sheryl Giambartolomei, RN

Telephone: 1-303-765-3536

Email: sherylgiambartolomei@centura.org

Principal Investigator: John Campana, MD

United States, Minneapolis, Minnesota

Virginia Piper Cancer Institute, part of Allina Health System

Minneapolis, Minnesota, United States, 55407

Contact: Stephanie Erickson

Telephone: 1-612-863-1752

Email: Stephanie.Erickson2@allina.com

Principal Investigator: Joseph Leach, MD

United States, Philadelphia, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Contact: Anthony Roberts

Telephone: 215-955-8546

Email: Anthony.Roberts@jefferson.edu

Principal Investigator: David Cognetti, MD

How long will the study take?

The total duration for an enrolled study participant is one month. The study will involve two procedures followed by a few outpatient visits to the hospital. The two procedures will involve (i) the administration of the drug, RM-1929, by intravenous infusion AND (ii) the illumination of the tumor with red light using a laser to activate cancer cell killing. Light illumination is applied 24 hours after the infusion of RM-1929 study drug administration.

The follow-up visits to the hospital will be scheduled four days, one week, two weeks, and one month after the RM-1929 drug infusion.

What are the potential risks for study participants?

RM-1929 is an investigational drug—a drug that is being tested and is not approved for sale in the USA by the U.S. Food and Drug Administration (FDA). The red light laser used to activate RM-1929 is also an investigational device that has not been approved for sale in the USA by the FDA.

Study participants may experience side effects while on the research study. Side effects may include mild to severe local swelling and/or pain, which may affect speaking, breathing, or swallowing; bleeding; shortness of breath; chest pain; dehydration; blood electrolyte changes; hypotension or weight loss. Side effects may be mild or very serious, and brief or longstanding. Study participants may also experience additional unknown side effects.